S.1095 - Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act; Stop STALLING Act (119th Congress)
Summary
S.1095, the Stop STALLING Act, aims to curb the filing of sham citizen petitions that attempt to obstruct the approval of generic drugs and biosimilars. The bill empowers the Federal Trade Commission (FTC) to take action against those who submit such petitions with the intent of interfering with competitors' businesses. It seeks to foster competition and ensure that legitimate public health concerns are addressed efficiently.
Expected Effects
The Act will likely reduce the number of frivolous petitions filed to delay generic drug approvals. This could lead to faster market entry for generic drugs and biosimilars, potentially lowering drug costs for consumers. The FTC would have increased authority to penalize anti-competitive behavior in the pharmaceutical industry.
Potential Benefits
- Increased competition in the pharmaceutical market.
- Reduced drug costs for consumers due to faster generic drug approvals.
- Deterrence of anti-competitive practices by pharmaceutical companies.
- More efficient review of legitimate citizen petitions raising public health concerns.
- Enhanced FTC enforcement capabilities against sham petitions.
Potential Disadvantages
- Potential for increased litigation as companies challenge FTC determinations of 'sham' petitions.
- Risk of chilling legitimate citizen petitions if individuals or organizations fear FTC penalties.
- Possible delays in addressing genuine public health concerns if petitions are scrutinized too heavily.
- Increased administrative burden on the FTC to investigate and prosecute sham petitions.
- Difficulty in definitively proving the 'intent' behind a petition, leading to legal challenges.
Constitutional Alignment
The bill's focus on regulating anti-competitive practices aligns with the Commerce Clause (Article I, Section 8), which grants Congress the power to regulate interstate commerce. The First Amendment protects the right to petition the government, but this right is not absolute and can be restricted when used for unlawful purposes, such as interfering with competition. The bill includes provisions for due process, allowing defendants to challenge the FTC's findings.
Impact Assessment: Things You Care About ⓘ
This action has been evaluated across 19 key areas that matter to you. Scores range from 1 (highly disadvantageous) to 5 (highly beneficial).